NCT01221974已完成1 期
Use of Essure® Micro-inserts in Women With Hydrosalpinx Prior to In Vitro Fertilization: A Prospective, Multicenter, International Feasibility Study
Reproductive Science Center2 个研究点 分布在 1 个国家开始时间: 2008年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to gather safety data related to the use of Essure® micro-inserts in women with hydrosalpinx prior to in vitro fertilization and during pregnancy and to collect data with regard to implantation rates, clinical pregnancy rates, and pregnancy outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age 21-38 (unless women in ovum donor cycle then age will be included up to 43) who:
- •Are willing to participate in this clinical study Are able to comprehend and give informed consent for participation in this study Have read, understood and signed an informed consent form Have been unable to achieve pregnancy after trying for 1 year or greater and who have unilateral or bilateral hydrosalpinges as evidenced by laparoscopy or ultrasound or HSG Have a Day #3 serum FSH<10, and Day #3 Estradiol<80 Recipient women undergoing a ovum donor cycle the donor must have a Day 3 serum FSH < 10 and Day 3 Estradiol < 80 Have an antral follicle count 10 or greater for both ovaries combined, if women using ovum donor (follicle count) will be based on eligible donor Have a desire to receive treatment for their HS Are willing to undergo a hysterosalpingogram (HSG) 3 months after Essure placement to confirm proximal tubal occlusion
排除标准
- •Active or recent upper or lower pelvic infection Known hypersensitivity to nickel as confirmed by skin test Known allergy to contrast media Pregnancy or suspected pregnancy Delivery or termination of pregnancy less than six weeks prior to Essure micro-insert placements BMI > 35 Abnormal pap smear (CIN2 or greater abnormality) within the past year Pelvic malignancy Severely retroverted uterus Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum Abnormal Clomid Challenge Test or abnormal lab values on Day #3 serum FSH and Estradiol Antral follicle count less than 10 (both ovaries combined) Poor general or gynecologic health Inability or refusal to provide informed consent
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Improvement of Symptoms After Removal of the Essure® Contraceptive ImplantImplant ComplicationContraceptive Device ComplicationsNCT06355713Hospices Civils de Lyon444
已完成
不适用
Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in WomenContraceptionNCT01948882Bayer660
终止
2 期
Hysteroscopic Lymphatic Mapping for Endometrial CancerEndometrial CancerNCT00671606M.D. Anderson Cancer Center5
已完成
3 期
Recombinant Hyaluronidase in Out-of-Hospital Setting: The EASI Access TrialMass Casualty IncidentDehydrationNCT00386386Massachusetts General Hospital20
已完成
不适用
A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary IncontinenceStress Urinary IncontinenceNCT01762345Procter and Gamble148